Kornimate/medical-research-clean huggingface dataset:
evaluation of long-term immunogenicity and safety of a human papillomavirus (hpv) vaccine in healthy female subjects

Conditions: Infections, Papillomavirus

Summary: infection with human papillomavirus (hpv) has been clearly established as the necessary cause of cervical cancer. this study is designed to evaluate the long-term immunogenicity and safety of the gsk biologicals' 580299 hpv vaccine up to 10 years after administration of the first dose of hpv vaccine (month 0) in primary study nct00196937. this protocol posting deals with objectives \& outcome measures of the extension phase from year 5 to year 10. the objectives \& outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (nct00196937).

subjects were aged 15-55 years at the time of entry into the primary study (nct00196937). no vaccine was administered in this extension study. results on outcome measures describing analyses on other studies are not reported in this record. please refer to the records mentioned in the respective outcome measure titles.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believed that they could and would comply with the requirements of the protocol. * a female who had been enrolled in nct00196937 study and received three doses of hpv-16/18 vaccine. * written informed consent obtained from the subject. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. * administration or planned administration of any hpv vaccine, other than the three doses of hpv-16/18 vaccine administered in nct00196937 study.

Keywords: cervical cancer hpv vaccine
a multicenter study of retrospective rehabilitation medical data for the development for medical twins

Conditions: Health-Related Behavior; Stroke

Summary: based on previous studies, when medical digital twin-based convergence medical contents are applied to degenerative musculoskeletal and central nervous system diseases, it is possible to more accurately evaluate the subject's motor function and neurological function to predict the subject's disease. in order to create an effective ict application protocol and clinically apply a treatment program that can improve the subject's kinematic function and neurological function, etc.


Eligibility criteria:
1. inclusion criteria: * healthy subjects : who underwent imaging examination at bundang cha hospital from january 1, 2010 to december 31, 2021 * stroke patients : who underwent imaging examination at bundang cha hospital from january 1, 2010 to december 31, 2021 2. exclusion criteria - who cannot meet the inclusion criteria
effects of whole egg consumption on inflammation, mood, and recovery in collegiate female gymnasts

Conditions: Inflammation

Summary: the objectives were to investigate the effects of whole egg consumption by collegiate female gymnasts on inflammatory markers, mood, and recovery.


Eligibility criteria:
inclusion criteria: * membership on the university gymnastics team exclusion criteria: * egg allergies, asthma, coronary artery disease, depression, diabetes, hypertension, migraines, cancer or cancer-related complications, or auto-immune disorder
effect of atorvastatin on fractional flow reserve in coronary artery disease

Conditions: Coronary Artery Disease

Summary: natural course of intermediate coronary artery disease (cad) is very important to predict the prognosis of the patient with such disease. several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the progression of cad with the modification of lipid profiles. this effect can be also explained by intravascular ultrasound (ivus) or optical coherence tomography. however, the effect of plaque modification on coronary physiology has been rarely evaluated. this research is to evaluate the change of intermediate or nonculprit coronary lesion on lipid-lowering therapy via ivus(optional) and ffr.

the patients who have intermediate cad (30-80% diameter stenosis by visual estimation) with ffr≥0.80, or nonculprit coronary artery disease with ffr≥0.8 after culprit coronary artery disease intervention will be enrolled. ffr, ivus(optional) and index of microcirculatory resistance (imr) should be performed simultaneously. atorvastatin 20mg is a starting dose, then up-titration will be done twice within each 4\~6weeks until ldl target goal (① ldl\ 50% reduction from baseline ldl, current statin user: \>30% reduction from baseline ldl). first titration will be atorvastatin 40mg, second will be atorvastatin 80mg. if patients have any adverse effect on atorvastatin, the dose of atorvastatin can be adjusted by investigator's decision. official clinical follow-up except visit for statin dose titration will occur at 1, 12 months after index procedure. follow-up coronary angiography, ffr,imr,and ivus(optional) will be performed 12 months after index procedure.

Eligibility criteria:
inclusion criteria: * patient \> 18 years of age and willing to participate * patients who have stable intermediate cad(30-80% diameter stenosis by visual estimation) on angiography with ffr≥0.8,or who have nonculprit cad which is not planned revascularization * signed written informed consent exclusion criteria: * patients who are in cardiogenic shock * patients with lvef\<35% * patients with left main disease, restenotic, bypass grafted lesions * patients with platelet count \< 100,000 cell/mm3 * patients who have co-morbidity which reduces life expectancy to one year * patients who have a history of stroke or transient ischemic attack within 6 months * patients who are planned discontinuation of medication due to surgery * patients with known adverse reaction to hmg co-a reductase therapy (statins) * patients with liver disease (elevation of ast or alt more than 2 times) * patient with creatinine \> 2.0 mg/dl * pregnant women and women of childbearing potential who intend to have children during the duration of the trial * patients who consistently must take drugs affecting lipid levels in blood except the investigational product
ctcs in cervix cancer

Conditions: Cervical Cancer; HPV

Summary: this study is a validation study to confirm the ability of telomescan obp-401 to identify ctcs in patients with hpv 16 / 18 associated cervical cancer. ctcs identified will be tested for the presence of the hpv 16 / 18 e6 protein, confirming a cervical cancer origin.


Eligibility criteria:
inclusion criteria: * able to safely provide 15 ml of blood * able to provide informed consent * pathologically confirmed invasive cervical cancer * proof of serotype hpv 16 or hpv 18 positive within 3 years of the study * patients with stages iia2 to ivb or recurrent cervical cancer * for patients with newly diagnosed cervical cancer, they must be enrolled (blood drawn) prior to initiating anti-cancer therapy * for patients with recurrent cervical cancer, they must be enrolled (blood drawn) prior to initiating a new anti-cancer therapy for progression of disease (based on recist 1.1 criteria). patients who have progressed and are moving to best supportive care are eligible. * if patients meet criteria 5.1a 5 above, the following criteria must be met: * at least 21 days have elapsed following treatment with cytotoxic chemotherapy * at least 14 days have elapsed following treatment with biologic therapy * at least 14 days have elapsed following radiation therapy exclusion criteria: * history of any cancer other than cervix cancer within the past five years. * history of any known germ-line pathogenic mutation (ie brca 1 / 2 or lynch syndrome, but genetic testing is not required) * current use of systemic corticosteroids at doses exceeding 10 mg per day of prednisone or its equivalent. * active infection including hepatitis b, hepatitis c, hiv. * any patient unable to comply with the study criteria. * patients taking any anti-inflammatory agents (aspirin, nsaids, steroids), within 24 hrs prior to blood draw.
roadster 3 extended follow-up sub-study

Conditions: Carotid Artery Diseases

Summary: the study objective is to evaluate long-term outcomes for participants enrolled in the roadster 3 study and treated with the enroute transcarotid stent system (tss) and enroute transcarotid neuroprotection system (nps).

this is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the enroute transcarotid stent system and the enroute transcarotid neuroprotection system in the roadster 3 study.

Eligibility criteria:
inclusion criteria: * participants who were enrolled in the roadster 3 study and treated with the enroute tss and enroute nps * able to provide informed consent exclusion criteria: * participants who have exited the roadster 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study

Keywords: long-term follow-up tcar
cooling the uterus in c-section after dysfunctional labor

Conditions: Blood Loss; Dysfunctional Labor; Uterine Atony

Summary: the objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section for dysfunctional labor.

two hundred patients will be drawn from all pregnant women who require a cesarean delivery for dysfunctional labor. dysfunctional labor will be defined as cervical dilation of 3 or more centimeters, in active labor without cervical change for 2 or more hours. patients will be randomly assigned to the study group or the control group, and each group will have 100 patients. following the delivery of the fetus, patients in the control group will have iv pitocin administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. additional utero-tonic medications may be given to improve uterine contraction. in the study group, following the delivery of the fetus, the uterus will be externalized in the usual fashion, except the uterus will be wrapped with lap sponges saturated in sterile, iced normal saline. additional utero-tonic medications may also be given in the study group to improve uterine contraction. immediately after the delivery of the fetus and prior to the delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the suction canister. this amount of fluid in the suction canister will be noted and subtracted from the amount of fluid in the canister at the conclusion of the surgery. at the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. post surgical vaginal bleeding will be monitored and calculated until the patient is discharged from the labor and delivery unit. use of utero-tonic medications will be recorded. at the conclusion of the study, the amount of blood loss and utero-tonic drugs between the control and study groups will be compared. the need for additional surgeries, such as a hysterectomy or d\&c, will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * pregnant women of any age * gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study. exclusion criteria: * women who refuse to be in the study * women who are unable to consent due to emergent nature of the cesarean section * women who are unable to understand the nature of the study due to mental illness, mental retardation, medical condition, or other communication barrier will be excluded.
integrated treatment for opioid use disorder and ptsd

Conditions: Opioid Use Disorder; Posttraumatic Stress Disorder (PTSD)

Summary: this study will test a therapy intervention, hope, for individuals with opioid use disorder and posttraumatic stress disorder. interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

up to half of individuals with oud have ptsd, but to date, there are no established evidence-based behavioral interventions that concurrently address oud and ptsd symptoms. the proposed study directly addresses this major clinical gap by testing whether augmenting medications for oud by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring ptsd (i.e., helping opioid use and ptsd with exposure; hope) will enhance clinical outcomes. the investigators will test hope combined with medications for oud (moud) versus moud-only in a randomized clinical trial among 76 individuals with oud and ptsd to evaluate feasibility and preliminary efficacy in reducing opioid use and ptsd severity. both conditions will also complete ecological momentary assessments (ema) to assess for daily opioid use, craving, and ptsd symptoms. ema will allow for the assessment of the associations between daily ptsd symptoms and opioid craving and use, which may then inform treatment development.

Eligibility criteria:
inclusion criteria: * any gender; any race or ethnicity; aged 18-70 years old. * english-speaking * meet dsm-5 diagnostic criteria for oud. * meet dsm-5 diagnostic criteria for ptsd and have some memory of their index traumatic event. * must be maintained on a stable dose of medication for oud for at least 1 month. * participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation. exclusion criteria: * participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically. * participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., moud refusal, risky fentanyl use, etc.), as determined by the pi and study team. these individuals will complete a safety plan and be referred for treatment. * participants meeting dsm-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. these participants will be referred clinically for treatment. * participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or ptsd outside of medications for oud and standard psychotherapy groups in treatment programs. * medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.

Keywords: mental health psychiatry substance use ptsd opioid use therapy
effect of different courses of lactobacilli treatment on bacterial vaginosis and pregnancy outcomes

Conditions: Bacterial Vaginosis

Summary: the purpose of this study is to examine the effect of lactobacillus preparation on bacterial vaginosis (bv) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. it is assumed that the living preparation of lactobacillus was beneficial for treatment of bv during pregnancy. the two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative bv positive patients comparing with one-course one.

research method: this was a single-blind randomized controlled trial. diagnostic standard: the study population is the women who have positive outcome of screened test for bv by sialidase method. allocation and follow up: patients who were screened for bv by sialidase method and randomly allocated into control group、one-course group and two-course group. the patients in control group who were bv positive would receive lotion washout and be repeatedly evaluated bv status per two weeks and be followed up to the 4th～7th days of postpartum. the patients in one-course group and in two-course group who were bv positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated bv status after treatment. the patients in two-course group will receive the second course treatment of lactobacilli preparation if their bv test result were still positive after one-course treatment, but those in one-course group would not receive any treatment even though they would have the durative bv positive result after one-course of lactobacilli. the patients in the two interventional groups would be repeatedly evaluated bv status at 28th gestational weeks and be followed up to the 4th-7th days of postpartum. all the inspection results of vaginal secretions and pregnancy outcome were recorded. outcome measures: * the prevalence of bv,the response rates of lactobacillus preparation,the recurrence rate. * the adverse pregnancy outcomes of mother. * the adverse pregnancy outcomes of perinatal fetus.

Eligibility criteria:
inclusion criteria: * pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes. exclusion criteria: * who have menstrual disorder or forget the last menstrual period, and have no type-b ultrasonic result, so the gestational week is not clear. * who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases. * who have severe medicochirurgic diseases. * multiple pregnancy. * anomalies of genital tract * fetal anomaly

Keywords: bacterial vaginosis probiotics lactobacilli pregnancy outcome randomized controlled trial
assessment of right ventricular function in patients with severe mitral stenosis before and after balloon mitral valvuloplasty

Conditions: Mitral Stenosis

Summary: to detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function

in patients with mitral valve stenosis, right ventricular failure may develop either by the rheumatic process directly or through hemodynamic alterations resulting from pulmonary vascular changes. right ventricular (rv) function plays an important role in development of clinical symptoms and prognosis in patients with mitral stenosis (ms).this is primarily affected by hemodynamic effects on rv due to pulmonary hypertension(ph). in the last two decades, percutaneous transluminal mitral commissurotomy (ptmc) has become the treatment of choice for patients with symptomatic rheumatic ms . using this method,mitral valve area (mva) can be increased, which can improve the hemodynamic and clinical features of patients with ms . rv functional assessment is difficult and not done routinely because of its complex anatomy and high load dependence. different modalitis are used to assess rv function as tissue doppler and two-dimensional (2d) speckle tracking method has been used to quantify strain for assessment myocardial strain is a measure of tissue deformation, which is expressed as a percentage change.

Eligibility criteria:
inclusion criteria: * patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for ptmc by 2d echo evaluation). * patient with normal left ventricular ef. * patient with sinus rhythm or af * patient with any degree of pulmonary htn exclusion criteria: * patient with another valve lesion or more than mild mitral regurgitation. * patient with impaired cardiac function. * patient with coronary arteries disease * mitral stenosis of other etiology than rheumatic origin.
tiotropium plus olodaterol vs inhaled corticosteroids (ics) regimens in the portuguese primary care setting (tiolcor study)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: what are the differences between patients prescribed a new maintenance treatment for chronic obstructive pulmonary disease (copd) with tiotropium/olodaterol (tio/olo) or inhaled corticosteroids (ics)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?


Eligibility criteria:
inclusion criteria: 1. aged ≥ 40 years at the date of copd diagnosis. 2. diagnosis of copd confirmed by the investigator. a spirometry confirming the diagnosis (fev1/forced vital capacity \[fvc\] ratio \<0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records. 3. prescription of a new maintenance copd treatment with tio/olo or ics-containing regimens (not including tio/olo) 3 months (-7/+30 days) prior to the inclusion visit. the copd treatment may have been prescribed at primary care sites or at the hospital. 4. written informed consent prior to participation. exclusion criteria: 1. respiratory disorders other than copd, such as asthma-copd overlap or asthma (prior to or at the index date). 2a. for treatment naïve patients (i.e., those who have never started a maintenance therapy for copd \[with either short- or long-acting bronchodilators or ics\]) - no data on the gold 2019 group at the index date is available in the medical records. patients may still be included if the determination of the gold 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mmrc and copd assessment test (cat) at the index date). 2b. for treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. patients may still be included if this information is obtained based on patient interviews. 3. participation in a clinical trial within the 3 months prior to the inclusion visit.
validation of ferromagnetic tracer in melanoma sentinel node

Conditions: Melanoma Stage; Sentinel Lymph Node

Summary: this study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (spio) tracer respect to the traditional isotopic method. both methods are used in every included patient and each patient is its own control.

* injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day). * identical injection in three-four punctures of 2 ml of sienna+ ® and local massage of 5-10 minutes. * optional: colorant injection in standard form. local massage of 5-10 minutes. * after 20 minutes: transcutaneous measurement with sentimag® * valuing territories (lymphoscintigraphy information?) * surgical identification measures: 1. st with sentimag® 2. nd with gamma detection probe * ex vivo check and hrd record

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years of age), * with diagnosis of cutaneous melanoma and * in which slnb is indicated as a staging method, and * with cn0 result after clinical-echographic-cytohistological evaluation. exclusion criteria: * previous treatment with systemic therapy. * recent previous surgery (\<3 months) in the area susceptible of lymphatic drainage from the melanoma. * intolerance or hypersensitivity to iron or dextran compounds. * impossibility of use of radioisotope. * existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin). * implantation of pacemakers or partially or totally metallic thoracic implants. * treatment with iron chelators (deferasirox, deferoxamine, ...).

Keywords: cutaneous melanoma sentinel node biopsy